Materials
materials, manufacturing processes, sterilisation, packaging, patient contact and clinical performance. “A material that looks ideal from an engineering perspective may introduce significant chemical characterisation, toxicological or clinical evidence requirements,” he adds. “If those are not identified until verification or submission, the manufacturer may face additional testing, redesign or significant delays. The modern approach is to bring regulatory, biological safety and quality considerations into development much earlier.”
This instinctively sounds highly pragmatic. Biocompatibility, extractables and leachables, long- term safety evidence and other inputs affect how quickly a device can move through development. Bad choices can create expensive consequences down the line, so companies no longer select materials primarily for performance but also for their regulatory implications.
Materials strategy is moving earlier in device development rather than remaining a downstream engineering task. However, as companies choose materials with established regulatory and clinical histories rather than those that may be technically optimal, this shift may have downsides.
Shifts in the regulatory landscape Developers must deal with the changing reality of the approval process. In the US, the FDA has issued guidance and draft guidance containing more detailed recommendations on chemical characterisation as one component of biocompatibility assessment. These developments sit alongside the agency’s partial recognition of ISO 10993-1:2025 in May 2026.
This can be viewed as a shift away from asking only what material a device is made from and whether it passes biocompatibility tests, towards analysing which chemicals could reach the patient from the finished device and at what levels, how reliably they have been identified and what exposure could mean toxicologically. The FDA’s September 2023 final guidance on ISO 10993-1 emphasises evaluating the finished device, including its materials, manufacturing processes, sterilisation and relevant residues. In May 2026, the agency also partially recognised ISO 10993-1:2025, the standard’s sixth edition.
The FDA does not clear or approve individual materials. Its assessment concerns the finished device and therefore considers the material, manufacturing processes, sterilisation and residuals from manufacturing aids. Its September 2024 draft guidance, Chemical Analysis for Biocompatibility Assessment of Medical Devices, sets out recommended approaches for conducting and reporting chemical analysis studies. As draft guidance, it represents the FDA’s current thinking rather than a binding requirement.
www.medicaldevice-developments.com
Biocompatibility assessments increasingly use chemical characterisation and toxicological risk assessment alongside, or to inform the need for, biological endpoint testing. Historically, a manufacturer might have approached biocompatibility by selecting tests associated with the device’s contact type and duration, but ISO 10993-1 frames biological evaluation as a risk- management process rather than a fixed checklist. In Europe, the EU Medical Device Regulation requires manufacturers to maintain risk management, technical documentation, clinical evaluation and post-market surveillance processes throughout the device life cycle, including relevant information about materials and biological risks. Under MDR Annex I, manufacturers must establish, implement, document and maintain a risk-management system that is systematically updated, so the choice of polymer, alloy, adhesive or coating does not disappear from the design history once the product launches.
“Developers and entrepreneurs better understand the regulatory system and plan in advance for what is needed to get approval.”
Professor Buddy Ratner
Furthermore, Annex II requires the technical documentation to include relevant verification and validation information, including device biocompatibility and physical, chemical and microbiological characterisation. The regulation requires evidence demonstrating that the finished device conforms to applicable safety and performance requirements, including relevant evidence on biocompatibility and material characterisation.
Entering the age of ‘design for approval’
Material decisions are moving beyond which polymer or metal will perform best. Instead, materials selection has become a regulatory and market-access decision.
“Everyone is considering it earlier, as there is a better understanding of what the US FDA and other regulators require,” says Buddy Ratner, professor of bioengineering and chemical engineering at the University of Washington. “The FDA has not necessarily intensified requirements, but developers and entrepreneurs better understand the regulatory system and plan in advance for what is needed to get approval.”
There is a shift towards regulatory affairs teams entering the development process earlier, materials information being considered before concepts are finalised and greater preference for materials with established clinical histories.
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